Allergic Rhinitis
Conditions
Brief summary
The purpose of this study is to find out if the bacteria present in the nose or sinuses of people with seasonal allergies changes during their allergy season. Another purpose of this study is to see if the bacteria present in the nose and sinuses of non-allergic people are the same as allergic people before the allergy season and if it changes during the season. Many bacteria are difficult to grow in the laboratory so the investigators are using analysis of DNA (the genetic material in cells) of the bacteria in the nose and sinus to find them. The investigators will be testing DNA of the bacteria only and not of the human subjects taking part in this study. This research is being done to help us understand how allergy affects bacteria in the nose and sinuses.
Interventions
OTHERSwab of vestibule and middle meatus of nose
Swabs of vestibule and middle meatus of nose will be taken prior to and during the grass/tree allergy season
Sponsors
Merck Sharp & Dohme LLC
University of Chicago
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males and females between 18 and 55 years of age. 2. History of tree and/or grass allergic rhinitis for at least 2 years (allergic subjects) or no allergy history at all (normal controls). 3. For allergic subjects, a positive skin test to trees and/or grass antigen within prior 12 months. For non-allergic subjects, negative skin tests to common allergens in the Chicago area.
Exclusion criteria
1. Respiratory disease other than allergic rhinitis, allergic conjunctivitis and mild asthma. 2. Use of nasal steroids, antihistamines in the last 4 weeks. 3. Upper respiratory infection, sinusitis less than 2 weeks before screening. 4. Structural nasal abnormalities or nasal polyps on examination, nasal ulcer, frequent nose bleeding, recent nasal surgery or nasal trauma (within 90 days). 5. Participation in other investigational therapy in the last 30 days. 6. Any systemic disorder or medication interfering with the study. 7. Undergoing allergen desensitization therapy. 8. Not willing to give informed consent 9. Inability to understand the nature and requirements of the study, or to comply with the study procedures. 10. Any social or medical condition that, in the opinion of the investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in bacterial profile of the sinuses | Measured at baseline and 1 to 3 months later. | DNA isolation to determine the bacterial profiles of samples taken at baseline (out of subjects' allergy season) and 1 to 3 months later during subjects' allergy season. |
Countries
United States
Outcome results
None listed